VTX (GE Cataolg No. B7005A)
FDA 510(k) K792067 · General Electric Co.
510(k) numberK792067
Submission
- Device name
- VTX (GE Cataolg No. B7005A)
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- October 15, 1979
- Decision date
- December 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was VTX (GE Cataolg No. B7005A) cleared by the FDA?
VTX (GE Cataolg No. B7005A) (K792067) received a 510(k) decision of Substantially Equivalent on December 10, 1979, 56 days after the submission was received.
What is the product code of K792067?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.